UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
|X| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2003
OR
|_| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from _____________ to _____________
Commission file number 000-26422
DISCOVERY LABORATORIES, INC.
(Exact name of registrant as specified in its charter)
Delaware 94-3171943
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
350 South Main Street, Suite 307
Doylestown, Pennsylvania 18901
(Address of principal executive offices) (Zip Code)
(215) 340-4699
(Registrants' telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. |X| Yes |_| No
Indicate by check mark whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Exchange Act). |_| Yes |X| No
As of October 22, 2003, 42,297,545 shares of common stock, par value $.001 per
share, were outstanding.
Table of Contents
Page
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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
CONDENSED CONSOLIDATED BALANCE SHEETS --
As of September 30, 2003 (unaudited) and December 31, 2002 ................................... Page 4
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) --
For the Three Months Ended September 30, 2003 and 2002;
for the Nine Months Ended September 30, 2003 and 2002; and
for the Period from May 18, 1993 (Inception) through September 30, 2003 ...................... Page 5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) --
For the Nine Months Ended September 30, 2003 and 2002; and
for the Period from May 18, 1993 (Inception) through September 30, 2003 ...................... Page 6
Notes to Condensed Consolidated Financial Statements
- September 30, 2003 (unaudited) ............................................................. Page 7
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations ........... Page 8
Item 3. Quantitative and Qualitative Disclosures about Market Risk ...................................... Page 23
Item 4. Controls and Procedures ......................................................................... Page 23
PART II - OTHER INFORMATION
Item 1. Legal Proceedings. .............................................................................. Page 24
Item 2. Changes in Securities and Use of Proceeds. ...................................................... Page 24
Item 3. Defaults Upon Senior Securities. ................................................................ Page 24
Item 4. Submission of Matters to a Vote of Security Holders. ............................................ Page 24
Item 5. Other Information. .............................................................................. Page 24
Item 6. Exhibits and Reports on Form 8-K. ............................................................... Page 25
Signatures ............................................................................................... Page 26
Page 2
Unless the context otherwise requires, all references to "we," "us," "our," and
the "Company" include Discovery Laboratories, Inc. ("Discovery"), and its
wholly-owned, presently inactive subsidiary, Acute Therapeutics, Inc.
Safe Harbor Statement Under the Private Securities Litigation Act of 1995
Certain statements set forth in this report and any that are incorporated by
reference herein which are not historical, including, without limitation,
statements concerning our research and development programs and clinical trials,
the possibility of submitting regulatory filings for our products under
development, the seeking of collaboration arrangements with pharmaceutical
companies or others to develop, manufacture and market products, the research
and development of particular compounds and technologies and the period of time
for which our existing resources will enable us to fund our operations,
constitute "Forward Looking Statements" within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
We intend that all forward-looking statements be subject to the safe-harbor
provisions of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are only predictions and reflect our views as of the
date they are made with respect to future events and financial performance.
Forward-looking statements are subject to many risks and uncertainties which
could cause our actual results to differ materially from any future results
expressed or implied by the forward-looking statements.
Examples of the risks and uncertainties include, but are not limited to: the
inherent risks and uncertainties in developing products of the type we are
developing; possible changes in our financial condition; the progress of our
research and development (including the results of clinical trials being
conducted by us and the risk that our lead product candidate, Surfaxin(R), will
not prove to be safe or useful for the treatment of certain indications);
clinical trials require adequate supplies of drug substance and drug product,
which may be difficult or uneconomical to procure or manufacture; timely
obtaining sufficient patient enrollment in our clinical trials; the impact of
development of competing therapies and/or technologies by other companies; our
ability to obtain additional required financing to fund our research programs;
our ability to enter into agreements with collaborators and the failure of
collaborators to perform under their agreements with us; the progress of the FDA
approvals in connection with the conduct of our clinical trials and the
marketing of our products; the additional costs and delays which may result from
requirements imposed by the FDA in connection with obtaining the required
approvals; and the other risks and uncertainties detailed in Item 2:
"Management's Discussion and Analysis" and in any documents incorporated by
reference in this report.
Except to the extent required by applicable laws or rules, we do not undertake
to update any forward-looking statements or to publicly announce revisions to
any of the forward-looking statements, whether as a result of new information,
future events or otherwise.
Page 3
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
DISCOVERY LABORATORIES, INC. AND SUBSIDIARY
(a development stage company)
Condensed Consolidated Balance Sheets
September 30, December 31,
2003 2002
------------- -------------
(Unaudited)
Current assets:
Cash and cash equivalents $ 32,607,000 $ 8,538,000
Available -for-sale marketable securities 3,287,000 10,652,000
Note receivable - current 3,000 2,000
Prepaid expenses and other current assets 904,000 325,000
------------- -------------
Total current assets 36,801,000 19,517,000
Property and equipment, net of accumulated depreciation 1,905,000 1,231,000
Note receivable 193,000 195,000
Other assets 82,000 119,000
------------- -------------
Total Assets $ 38,981,000 $ 21,062,000
============= =============
LIABILITIES & STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $ 3,638,000 $ 3,013,000
Capitalized lease - current 312,000 189,000
------------- -------------
Total current liabilities 3,950,000 3,202,000
Deferred revenue 852,000 1,393,000
Credit facility with corporate partner 2,065,000 1,450,000
Capitalized lease, net of current portion 485,000 256,000
------------- -------------
Total Liabilities 7,352,000 6,301,000
Shareholders' equity:
Common stock, $.001 par value; 60,000,000 authorized;
42,080,094 and 32,818,283 issued and outstanding
at September 30, 2003 and December 31, 2002, respectively 42,000 33,000
Additional paid-in capital 120,980,000 87,463,000
Unearned portion of compensatory stock options (7,000) (95,000)
Deficit accumulated during development stage (88,151,000) (72,578,000)
Treasury stock (at cost; 167,179 and 38,243 shares at
September 30, 2003 and December 31, 2002, respectively) (1,289,000) (239,000)
Accumulated other comprehensive income 54,000 177,000
------------- -------------
Total shareholders' equity 31,629,000 14,761,000
------------- -------------
Total Liabilities & Equity $ 38,981,000 $ 21,062,000
============= =============
Page 4
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
DISCOVERY LABORATORIES, INC. AND SUBSIDIARY
(a development stage company)
Condensed Consolidated Statements of Operations
(Unaudited)
May 18, 1993
Three Months Ended Nine Months Ended (Inception)
September 30, September 30, through
----------------------------- ----------------------------- September 30,
2003 2002 2003 2002 2003
----------- ----------- ------------ ------------ ------------
Revenues:
Contracts, Licensing & Milestones $ 198,000 $ 368,000 $ 855,000 $ 1,388,000 $ 4,695,000
----------- ----------- ------------ ------------ ------------
Expenses:
Research & Development 5,096,000 3,475,000 12,950,000 9,801,000 55,667,000
General & Administrative 1,375,000 1,633,000 3,679,000 4,303,000 27,104,000
Write-off of acquired in-process
research and development
and supplies 13,508,000
----------- ----------- ------------ ------------ ------------
Total Expenses 6,471,000 5,108,000 16,629,000 14,104,000 96,279,000
----------- ----------- ------------ ------------ ------------
Operating Loss (6,273,000) (4,740,000) (15,774,000) (12,716,000) (91,584,000)
Other income and expenses:
Interest Income, dividends, realized
gains, and other income 116,000 256,000 382,000 607,000 4,458,000
Minority interest in net loss of
subsidiary 26,000
Interest expense (62,000) (45,000) (181,000) (77,000) (369,000)
----------- ----------- ------------ ------------ ------------
Net Loss $(6,219,000) $(4,529,000) $(15,573,000) $(12,186,000) $(87,469,000)
=========== =========== ============ ============ ============
Net loss per common share -
basic and diluted $ (0.15) $ (0.17) $ (0.43) $ (0.46)
Weighted average number of common
shares outstanding -
basic and diluted 41,084,355 26,440,880 35,809,252 26,222,925
Page 5
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
DISCOVERY LABORATORIES, INC. AND SUBSIDIARY
(a development stage company)
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Nine Months Ended May 18, 1993
September 30, (Inception)
--------------------------------- through
2003 2002 September 30, 2003
------------- ------------- -------------
Cash flows from operating activities:
Net loss $ (15,573,000) $ (12,186,000) $ (87,469,000)
Adjustments to reconcile net loss to net cash used
in operating activities:
Write-off of acquired in-process research and
development and supplies -- -- 13,508,000
Write-off of licenses -- -- 683,000
Depreciation and amortization 272,000 209,000 1,101,000
Compensatory stock options 104,000 169,000 3,681,000
Expenses paid using treasury stock and
common stock -- 26,000 230,000
Loss on sale of property -- -- 4,000
Changes in:
Prepaid expenses and
other current assets (579,000) 827,000 257,000
Accounts payable and accrued expenses 625,000 250,000 3,505,000
Other assets (1,000) 1,000 (24,000)
Proceeds from research and development
collaborative agreements -- 1,833,000 3,474,000
Amortization of deferred revenue (541,000) (807,000) (3,177,000)
Expenses paid on behalf of company -- -- 18,000
Employee stock compensation -- -- 42,000
Reduction of research and development supplies -- -- (161,000)
------------- ------------- -------------
Net cash used in operating activities (15,693,000) (9,678,000) (64,328,000)
------------- ------------- -------------
Cash Flows from Investing Activities:
Purchase of property and equipment (381,000) (332,000) (2,359,000)
Proceeds from sale of property and equipment -- -- 575,000
Loan to related party -- -- (200,000)
Related party loan payments received 1,000 2,000 4,000
Acquisition of licenses -- -- (711,000)
Purchase of marketable securities (271,000) (5,481,000) (52,775,000)
Proceeds from sale or maturity of marketable securities 7,513,000 10,963,000 49,947,000
Net cash payments on merger -- -- (1,670,000)
------------- ------------- -------------
Net cash provided by (used in) investing
activities 6,862,000 5,152,000 (7,189,000)
------------- ------------- -------------
Cash Flows from Financing Activities:
Proceeds from issuance of securities, net of expenses 33,510,000 2,956,000 103,519,000
Proceeds from credit facility 615,000 1,257,000 2,065,000
Purchase of treasury stock (1,050,000) -- (1,171,000)
Principal payments under capital lease obligation (175,000) (43,000) (289,000)
------------- ------------- -------------
Net cash provided by financing activities 32,900,000 4,170,000 104,124,000
------------- ------------- -------------
Net increase (decrease) in cash and cash equivalents 24,069,000 (356,000) 32,607,000
Cash and cash equivalents - beginning of period 8,538,000 3,758,000
------------- ------------- -------------
Cash and cash equivalents - end of period $ 32,607,000 $ 3,402,000 $ 32,607,000
============= ============= =============
Supplementary disclosure of cash flows information:
Interest paid $ 144,000 $ (37,000) $ 276,000
Noncash transactions:
Class H warrants issued/revalued -- (617,000) 150,000
Accrued dividends on Series C preferred stock -- -- 682,000
Series C preferred stock dividends paid using
common stock -- -- 204,000
Preferred Stock issued for inventory -- -- 575,000
Equipment acquired through capitalized lease 527,000 149,000 1,086,000
Unrealized (loss) gain on marketable securities (123,000) 116,000 54,000
Page 6
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 1 - THE COMPANY AND BASIS OF PRESENTATION
The Company
Discovery Laboratories, Inc. (the "Company"), is a biopharmaceutical company
developing its proprietary surfactant technology as Surfactant Replacement
Therapies for respiratory diseases including Respiratory Distress Syndromes,
Acute Lung Injury, asthma, Chronic Obstructive Pulmonary Disease (COPD), and
upper airway disorders. Surfactants are substances that are produced naturally
in the lungs and are essential to the lungs' ability to absorb oxygen and to
maintain proper airflow through the respiratory system. The absence or depletion
of surfactant is involved in a number of respiratory diseases. Our surfactant
technology produces an engineered version of natural human lung surfactant that
is designed to precisely mimic the essential properties of human lung
surfactant. We believe that our proprietary surfactant technology is the only
surfactant technology presently available to potentially treat a broad range of
respiratory diseases.
Our lead product, Surfaxin(R), is being developed for critical care patients
with life-threatening respiratory disorders where there are few, if any,
approved therapies. Surfaxin is currently in a pivotal Phase 3 clinical trial
for Respiratory Distress Syndrome in premature infants, a Phase 2 clinical trial
for Acute Respiratory Distress Syndrome in adults and a Phase 3 and a Phase 2
clinical trial for Meconium Aspiration Syndrome in full-term infants. Inhalable
aerosolized formulations of our humanized surfactant are presently being
developed to potentially treat patients suffering from severe acute asthma and
Acute Lung Injury, our lead preclinical programs, as well as COPD, sinusitis,
and upper airway disorders such as sleep apnea and otitis media (inner ear
infection).
We are developing a dedicated sales and marketing capability through a
collaboration with Quintiles Transnational Corp., to commercialize Surfaxin in
neonatal indications in the United States. We have also entered into a strategic
alliance with Laboratorios del Dr. Esteve to commercialize Surfaxin in Europe
and Latin America. We intend to establish strategic alliances, where
appropriate, for the development and commercialization of our products in other
indications and markets.
Stock Based Employee Compensation
The Financial Accounting Standards Board has issued Statement of Financial
Accounting Standards ("SFAS") No. 148, "Accounting for Stock-Based Compensation
- - Transition and Disclosure". SFAS No. 148 amends SFAS No. 123, "Accounting for
Stock-Based Compensation" to provide alternative methods of transition to a
voluntary change to the fair value based method of accounting for stock-based
employee compensation. In addition, SFAS No. 148 amends the disclosure
requirements of SFAS 123 to require prominent disclosure in both annual and
interim financial statements about the method of accounting for stock-based
employee compensation and the effect of the method used on the reported results.
We continue to account for our stock option plans in accordance with Accounting
Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees." Had
we accounted for our stock option plans in accordance with SFAS 123, the pro
forma net loss for the nine months ended September 30, 2003 and 2002 would have
been as follows:
Three Months Ended Nine Months Ended
September 30, September 30,
------------------------------- -------------------------------
2003 2002 2003 2002
------------ ------------ ------------ ------------
Net loss as reported $ (6,219,000) $ (4,529,000) $(15,573,000) $(12,186,000)
Additional stock-based employee compensation $ (3,475,000) $ (168,000) $ (4,486,000) $ (771,000)
------------ ------------ ------------ ------------
Pro forma net loss $ (9,694,000) $ (4,697,000) $(20,059,000) $(12,957,000)
============ ============ ============ ============
Pro forma net loss per share $ (0.24) $ (0.18) $ (0.56) $ (0.49)
Page 7
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been
prepared in accordance with accounting principles generally accepted in the
United States for interim financial information in accordance with the
instructions to Form 10-Q. Accordingly, they do not include all of the
information and footnotes required by accounting principles generally accepted
in the United States for complete financial statements. In the opinion of
management, all adjustments (consisting of normally recurring accruals)
considered for fair presentation have been included. Operating results for the
nine-month period ended September 30, 2003, are not necessarily indicative of
the results that may be expected for the year ended December 31, 2003. For
further information, refer to the consolidated financial statements and
footnotes thereto included in our Annual Report on Form 10-K, as amended, for
the year ended December 31, 2002.
We are a development stage company and have incurred substantial losses since
inception. To date, we have funded our operations primarily through the issuance
of equity. We expect to continue to expend substantial amounts for continued
product research, development and initial commercialization activities for the
foreseeable future. Management's plans with respect to funding these development
and commercialization activities are to use our existing capital, our secured
credit facilities with PharmaBio Development Inc., a subsidiary of Quintiles,
and General Electric Capital Corporation, and, if possible, to secure additional
capital through the issuance of equity and/or collaborative arrangements. Our
continuation is dependent on our ability to obtain additional financing and,
ultimately, on our ability to achieve profitable operations. There is no
assurance, however, that such financing will be available or that our efforts
ultimately will be successful.
All of our current products under development are subject to license agreements
that will require the payment of future royalties.
Certain prior year balances have been reclassified to conform with the current
presentation. The reclassification had no effect on net income.
NOTE 2 - NET LOSS PER SHARE
Net loss per share is computed based on the weighted average number of common
shares outstanding for the periods. Common shares issuable upon the exercise of
options and warrants and the conversion of convertible securities are not
included in the calculation of the net loss per share as their effect would be
antidilutive.
NOTE 3 - COMPREHENSIVE LOSS
Total comprehensive loss was approximately $6,294,000 and $15,696,000 for the
three and nine months ended September 30, 2003, respectively, and approximately
$4,424,000 and $12,070,000 for the three and nine months ended September 30,
2002, respectively.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
Overview
Since our inception, we have incurred significant losses and, as of September
30, 2003, had a deficit accumulated during the development stage of
approximately $88.2 million (including historical results of predecessor
companies). The majority of our expenditures to date have been for research and
development activities. Research and development expenses represent costs
incurred for scientific and clinical personnel, clinical trials, regulatory
filings and manufacturing efforts (including raw material costs). We expense our
research and development costs as they are incurred. General and administrative
expenses consist primarily of executive management, financial, business
development, legal and general corporate activities and related expenses.
Plan of Operations
We expect to continue to incur increasing operating losses for the foreseeable
future, primarily due to our continued research and development activities
attributable to new and existing products, manufacturing, initial
commercialization and general and administrative activities.
Page 8
We anticipate that during the next 12 to 24 months we will:
(i) significantly increase our research, development and regulatory
activities.
It is anticipated that our primary research and development
activities will be the several clinical trials for Surfaxin
indications and related regulatory filings. We are presently
conducting a pivotal, multinational landmark Phase 3 trial treating
up to 1,500 patients for the treatment of Respiratory Distress
Syndrome in premature infants. This pivotal trial is intended, if
successful, to provide the basis for New Drug Applications with the
FDA and other worldwide regulatory authorities. We expect to
announce top-line trial results in November 2003 for this clinical
trial. For Acute Respiratory Distress Syndrome in adults, we
currently are conducting a Phase 2 dose-ranging safety and efficacy
study of up to 110 patients in the United States. We expect to
complete enrollment for this trial in the second quarter of 2004.
For Meconium Aspiration Syndrome in full-term infants, we currently
are conducting a Phase 3 clinical trial of up to 200 patients in the
United States. Enrollment continues to be slower than expected and
completion is now anticipated in 2004. Given our belief in the
importance of the pivotal Phase 3 trial for Respiratory Distress
Syndrome in premature infants to our present development plan,
resources have been and may continue to be reallocated from the
Meconium Aspiration Syndrome program to the Respiratory Distress
Syndrome program, as needed. We are also conducting a Phase 2
clinical trial of Surfaxin lavage in up to 60 infant patients for
use as a prophylactic for infants who are at risk for Meconium
Aspiration Syndrome. The clinical trial and regulatory process is
lengthy, expensive and uncertain and subject to numerous risks
including, without limitation, the following risks discussed in the
"Risks Related to Our Business" section: "The clinical trial and
regulatory approval process for our products is expensive and time
consuming, and the outcome is uncertain"; and "Our technology
platform is based solely on our proprietary humanized, engineered
surfactant technology and only our lead product candidate, Surfaxin,
has been subject to clinical studies. Our ongoing clinical trials
for Surfaxin for the treatment of Respiratory Distress Syndrome in
premature infants may be delayed, or fail, which will harm our
business."
Aerosolized formulations of our humanized surfactant are presently
being developed to potentially treat hospitalized patients suffering
from severe acute asthma and Acute Lung Injury. In addition, we are
evaluating the development of aerosolized formulations of our
humanized surfactant to potentially treat COPD, sinusitis, sleep
apnea and otitis media (inner ear infection).
(ii) invest in and support a long-term manufacturing strategy that
includes further development and utilizing the clinical and
commercial supply capabilities of our current contract manufacturer
and securing additional manufacturing capability in order to provide
backup for the production of our humanized surfactant drug product
and to scale up to meet clinical and commercial needs as they
expand.
(iii) invest in additional general and administrative resources primarily
to support our business development initiatives, financial systems
and controls and management information technologies.
(iv) invest in marketing and commercialization management infrastructure
to manage the strategic relationships with our collaborative
partners for the launch of Surfaxin, if approved, and the execution
of our "Discovery/Surfaxin" worldwide marketing strategy.
We are currently implementing the initial phase of our long-term manufacturing
strategy through the recent selection of Laureate Pharma, L.P., to become our
current contract manufacturer. In October we entered into a Technology Transfer
and Manufacturing Agreement with Laureate Pharma which provides for the
establishment of a Surfaxin manufacturing line together with the production of
clinical and commercial drug supply in conformance with current Good
Manufacturing Practices (cGMP). This agreement also encompasses plans for
manufacturing scale-up and enhancements, including additional equipment to
support our anticipated commercial-scale requirements of Surfaxin for
Respiratory Distress Syndrome in premature infants and our anticipated
clinical-scale production requirements of Surfaxin for Acute Respiratory
Distress Syndrome in adults. See "Risks Related to Our Business - In order to
conduct our clinical trials we need adequate supplies of our drug substance and
drug product and competitors drug product, which may not be readily available";
and "If the parties we depend on for manufacturing our pharmaceutical products
do not timely supply these products, it may delay or impair our ability to
develop and market our products."
Page 9
We have entered into a collaboration arrangement with Quintiles, and its
affiliate, PharmaBio, to provide certain commercialization services in the
United States for Surfaxin for the treatment of Respiratory Distress Syndrome in
premature infants and Meconium Aspiration Syndrome in full-term infants.
Quintiles will hire and train a dedicated United States sales force that will be
branded in the market as ours. Quintiles will make available up to $70 million
in post-launch funding to cover the first seven years of United States sales and
marketing costs. In return, Quintiles will receive a commission on net sales of
Surfaxin over a 10-year period. The Quintiles arrangement allows us to retain
product ownership and have sales and marketing expertise in place for the
commercialization of Surfaxin in the United States, if approved.
We have an alliance with Esteve to develop, market and sell Surfaxin throughout
Europe and Latin America. Esteve will provide certain commercialization services
for Surfaxin for the treatment of Respiratory Distress Syndrome in premature
infants, Meconium Aspiration Syndrome in full-term infants and Acute Lung
Injury/Acute Respiratory Distress Syndrome in adult patients. Our exclusive
supply agreement with Esteve provides that Esteve will purchase from us all of
its Surfaxin drug product requirements at an established transfer price based on
sales of Surfaxin by Esteve and/or its sublicensee(s). Esteve has also agreed to
sponsor certain clinical trial costs related to obtaining regulatory approval in
Europe for the Acute Lung Injury/Acute Respiratory Distress Syndrome
indications. Esteve also agreed to make certain milestone payments to us upon
the attainment of European marketing regulatory approval for Surfaxin.
We will need to generate significant revenues from product sales and/or related
royalties and transfer prices to achieve and maintain profitability. Through
September 30, 2003, we have had no revenues from any product sales, and have not
achieved profitability on a quarterly or annual basis. Our ability to achieve
profitability depends upon, among other things, our ability to develop products,
obtain regulatory approval for products under development and enter into
agreements for product development, manufacturing and commercialization. In
addition, our results are dependent upon the performance of our strategic
partners and third party contract manufacturers and suppliers, including,
without limitation, our contract manufacturing facility. Moreover, we may never
achieve significant revenues or profitable operations from the sale of any of
our products or technologies.
Through September 30, 2003, we had not generated taxable income. On December 31,
2002, net operating losses available to offset future taxable income for federal
tax purposes were approximately $65.1 million. The future utilization of such
loss carryforwards may be limited pursuant to regulations promulgated under
Section 382 of the Internal Revenue Code. In addition, as of December 31, 2002,
we had a research and development tax credit carryforward of $1,225,000. The
federal net operating loss and research and development tax credit carryforwards
expire beginning in 2008 and continuing through 2021.
Results of Operations
Net loss for the three and nine months ended September 30, 2003 were $6,219,000
($0.15 per common share) and $15,573,000 ($0.43 per common share), respectively.
Net loss for the three and nine months ended September 30, 2002 were $4,529,000
($0.17 per common share) and $12,186,000 ($0.46 per common share), respectively.
Revenues
Revenues from research and development collaborative contracts and grants for
the three and nine months ended September 30, 2003 were $198,000 and $855,000,
respectively. Revenues from research and development collaborative contracts and
grants for the three and nine months ended September 30, 2002 were $368,000 and
$1,388,000, respectively. The decreased revenues are related to: (i) the
conclusion of work associated with our Small Business Innovative Research (SBIR)
grant for research in Acute Lung Injury/Acute Respiratory Distress Syndrome in
adults; (ii) our Orphan Products Development grant to develop Surfaxin for
Meconium Aspiration Syndrome in full-term infants; and (iii) the extension of
the amortization period and related revenue recognition of the funding
previously provided to us in connection with our strategic alliance with Esteve
which now reflects the planned fourth quarter 2003 completion of our Phase 3
pivotal clinical trial for Surfaxin for Respiratory Distress Syndrome in
premature infants.
Expenses
Research and development expenses for the three and nine months ended September
30, 2003 were $5,096,000 and $12,950,000, respectively. Research and development
expenses for the three and nine months ended September 30, 2002 were $3,475,000
and $9,801,000, respectively. This increase primarily reflects clinical trial
costs incurred for our lead product, Surfaxin, currently in various Phase 3 and
Phase 2 clinical trials for critical care patients with life threatening
respiratory disorders, research and development activities related to the
development of aerosolized formulations of our humanized lung surfactant, and
the transfer of our manufacturing capabilities in connection with the
implementation of the initial phase of our long-term manufacturing strategy.
Page 10
General and administrative expenses for the three and nine months ended
September 30, 2003 were $1,375,000 and $3,679,000, respectively. General and
administrative expenses for the three and nine months ended September 30, 2002
were $1,633,000 and $4,303,000, respectively. General and administrative
expenses consist primarily of the costs of executive management, financial and
accounting, business and commercial development, legal, facility and other
administrative costs. Included in general and administrative costs are
approximately $617,000 and $1,257,000 for the nine months ended September 30,
2003 and 2002, respectively, related to pre-launch commercialization activities
for Surfaxin conducted in connection with a collaboration arrangement with
Quintiles (for which funding is provided by the secured revolving credit
facility with PharmaBio discussed below in "Liquidity and Capital Resources").
Additionally, included general and administrative costs are non-cash
compensation charges of approximately $119,000 and $353,000 for the nine months
ended September 30, 2003 and 2002, respectively, related to options granted to
non-employee directors under the Automatic Option Grant Program of our Amended
and Restated 1998 Stock Option Plan and the vesting of certain stock options
granted to consultants.
Other Income and Expense
Other income and expense (net) for the three and nine months ended September 30,
2003 were $54,000 and $201,000, respectively. Other income and expense (net) for
the three and nine months ended September 30, 2002 were $211,000 and $530,000.
The decrease in other income and expense (net) is due primarily to interest
expense associated with our secured, revolving credit facility and capital lease
financing arrangements and a decrease in interest earned on our cash, cash
equivalents and marketable securities primarily due to a general reduction in
earned market interest rates. See "Liquidity and Capital Resources."
Liquidity and Capital Resources
Cash, Cash Equivalents and Marketable Securities
As of September 30, 2003, we had cash, cash equivalents and marketable
securities of approximately $35.9 million as compared to approximately $19.2
million we had as of December 31, 2002. As of September 30, 2003, we had working
capital of approximately $32.9 million as compared to the working capital of
approximately $16.3 million we had as of December 31, 2002. The increase in
working capital is due to the net proceeds of $33.5 million received from the
sale of securities and exercise of warrants, offset by funds used for operating
activities.
In June and July of 2003, our common stock attained certain price performance
thresholds on the Nasdaq SmallCap Market that permitted us to provide notice for
redemption (and thereby effectively compel the exercise thereof) to the holders
of three of our outstanding classes of warrants which represented, in aggregate,
the right to purchase approximately 3.6 million shares of common stock. Such
warrants (i.e., the Class I, Class F and Class C warrants) were previously
issued by us in connection with certain private placement financings that
occurred in November 2002, October 2001 and April 1999, respectively. Between
the dates of June 1, 2003 and September 12, 2003, holders of warrants
exercisable for approximately 3.6 million shares of common stock exercised such
warrants, in accordance with their respective terms, either cashlessly or for
cash, resulting in the issuance to the holders of approximately 3.3 million
shares of common stock and our receipt of aggregate cash proceeds equal to
approximately $6.1 million.
Secured, Revolving Credit Facility and Capital Lease Financing Arrangements
We have a secured revolving credit facility of up to $8.5 million to $10 million
with PharmaBio to fund pre-marketing activities for a Surfaxin launch in the
United States. The credit facility is available for use until December 10, 2004,
and monies become available in three tranches upon our satisfaction of certain
conditions. We have satisfied the conditions for availability of the first two
tranches and at September 30, 2003, the amount available under the credit
facility was approximately $5.7 million, of which $2.1 million was outstanding.
Interest on amounts advanced under the credit facility will be payable quarterly
in arrears. We may repay principal amounts owed by us under the credit facility
from proceeds of milestone payments to be paid to us by PharmaBio upon the
achievement of certain corporate milestones. We are obligated to use a
significant portion of the funds borrowed under the credit facility for
pre-launch marketing services to be provided by Quintiles.
Page 11
We have a capital lease financing arrangement with the Life Science and
Technology Finance Division of General Electric Capital Corporation. In
September 2003, the arrangement for up to $1 million was increased to provide,
subject to certain conditions, up to an aggregate $4 million in financing for
capital purchases. As of September 30, 2003, we had used approximately $765,000
of this financing arrangement.
Our working capital requirements will depend upon numerous factors, including,
without limitation, the progress of our research and development programs,
clinical trials, timing and cost of obtaining regulatory approvals, timing and
cost of pre-launch marketing activities, levels of resources that we devote to
the development of manufacturing and marketing capabilities, levels of resources
that our collaboration partners devote to the development of sales and marketing
capabilities, technological advances, status of competitors, our ability to
establish collaborative arrangements with other organizations, the ability to
defend and enforce our intellectual property rights and the establishment of
additional strategic or licensing arrangements with other companies or
acquisitions.
Historically, our working capital has been provided from the proceeds of private
financings:
In June 2003, we completed the sale of securities in a private placement to
selected institutional and accredited investors for net proceeds of
approximately $26.1 million. We issued 4,997,882 shares of common stock and
999,577 Class A Investor warrants to purchase shares of common stock at an
exercise price of $6.875 per share. The Class A Investor warrants have a
seven-year term. See Part II Item 2: "Change in Securities and use of Proceeds."
In November 2002, we completed the sale of securities in a private placement to
selected institutional and accredited investors for net proceeds of
approximately $11.9 million. We issued 6,397,517 shares of common stock and
2,878,883 Class I warrants to purchase shares of common stock at an exercise
price of $2.425 per share. The Class I warrants had a five-year term and we were
entitled to redeem the Class I warrants, with 60 days' prior written notice, for
$.001, upon the attainment of certain exchange-related price performance
thresholds of the common stock. In June 2003, the price performance criteria was
met and we provided notice to the Class I warrantholders of our intention to
redeem the Class I warrants. As of September 2, 2003, all Class I warrants have
been exercised.
Pursuant to our collaboration arrangement with Esteve on March 6, 2002, we
issued 821,862 shares of common stock to Esteve at a purchase price equal to
$4.867 per share and received a licensing fee of $500,000, for approximate net
aggregate proceeds of $4.45 million.
Pursuant to the collaboration arrangement we entered into with Quintiles and
PharmaBio in December 2001, we issued to PharmaBio, for approximate net
aggregate proceeds of $2.7 million: (i) 791,905 shares of common stock at a
price equal to $3.79 per share; and (ii) Class G warrants to purchase 357,143
shares of common stock at an exercise price equal to $3.485 per share (subject
to adjustment). In connection with the credit facility, we issued to PharmaBio
Class H warrants to purchase 320,000 shares of common stock. The Class H
warrants are exercisable at $3.03 per share (subject to adjustment) and are
exercisable proportionately only upon availability of the credit facility. To
the extent the credit facility availability is increased to greater than $8.5
million, for each $1 million increase, the amount of shares of common stock
issuable pursuant to the Class H warrants shall be increased by approximately
38,000 shares.
In October 2001, we received approximately $7.3 million in net proceeds from a
private financing. In the financing, we issued 3,562,759 shares of common stock
and 712,553 Class F warrants to purchase shares of common stock at an exercise
price equal to $2.365 per share. The Class F warrants had a five-year term and
we were entitled to redeem the Class F warrants, with 20 days' prior written
notice, for $.001, upon the attainment of certain exchange-related price
performance thresholds of the common stock. In July 2003, the price performance
criteria was met and we provided notice to the Class F warrantholders of our
intention to redeem the Class F warrants. As of August 13, 2003, all Class F
warrants have been exercised.
In April 2001, we received approximately $1 million in proceeds in a private
offering of 296,560 shares of common stock at a per share price equal to $3.37.
Page 12
In March 2000, we received approximately $17,500,000 in net proceeds in a
private placement offering from the sale of 2,902,846 shares of common stock and
580,567 Class E warrants to purchase common stock at $7.38 per share. The Class
E warrants issued in the offering are exercisable through March 2005.
In October 1999, in connection with our strategic alliance with Esteve, we
issued to Esteve in a private placement 317,164 shares of common stock at a
purchase price of $2.68 per share.
In July 1999, we raised approximately $2,233,000 in net proceeds in a private
placement offering of an aggregate of 2,024,792 shares of common stock and
2,024,792 Class D warrants to purchase common stock. All of the Class D warrants
have been exercised.
During March and April 1999, we raised $1.0 million in a private placement
offering of 826,447 shares of common stock and 569,026 Class C warrants to
purchase common stock at an exercise price of $2.15 per share. The Class C
warrants are exercisable through April 2006. In August 2003, pursuant to the
terms of the Class C warrants, we provided notice to the Class C warrantholders
of our intention to redeem the Class C warrants. As of September 12, 2003, all
Class C warrants have been exercised.
We will require substantial additional funding to conduct our business,
including our expanded research and product development activities. Based on our
current operating plan, we believe that our currently available resources,
including amounts currently available under our credit facility with PharmaBio,
and our capital lease financing arrangement with General Electric Capital
Corporation, will be adequate to satisfy our capital needs into 2005. Our future
capital requirements will depend on the results of our research and development
activities, clinical studies and trials, competitive and technological advances
and the regulatory process. Our operations will not become profitable before we
exhaust our current resources; therefore, we will need to raise substantial
additional funds through additional debt or equity financings or through
collaborative ventures with potential corporate partners. We may in some cases
elect to develop products on our own instead of entering into collaboration
arrangements and this would increase our cash requirements. Other than our
credit facility with PharmaBio and our capital lease financing arrangement with
General Electric Capital Corporation, we have not entered into any additional
arrangements to obtain any additional financing. The sale of additional equity
and debt securities may result in additional dilution to our stockholders, and
we cannot be certain that additional financing will be available in amounts or
on terms acceptable to us, if at all. If we fail to enter into collaborative
ventures or to receive additional funding, we may have to reduce significantly
the scope of or discontinue our planned research, development and
commercialization activities, which could significantly harm our financial
condition and operating results. Furthermore, we could cease to qualify for
listing of our common stock on the NASDAQ SmallCap Market if the market price of
our common stock declines as a result of the dilutive aspects of such potential
financings. See "Risks Related to Our Business - We will need additional
capital, and our ability to continue all of our existing planned research and
development activities is uncertain. Any additional financing could result in
equity dilution"; "The market price of our stock may be adversely affected by
market volatility"; and "A substantial number of our securities are eligible for
future sale and this could affect the market price for our stock and our ability
to raise capital."
Risks Related to Our Business
The following risks, among others, could cause our actual results, performance,
achievements or industry results to differ materially from those expressed in
our forward-looking statements contained herein and presented elsewhere by
management from time to time.
Because we are a development stage company, we may not successfully develop and
market our products, and even if we do, we may not generate enough revenue or
become profitable.
We are a developmental stage biopharmaceutical company; therefore, you must
evaluate us in light of the uncertainties and complexities present in such
companies. We currently have no products approved for marketing and sale and are
conducting research and development on our product candidates. As a result, we
have not begun to market or generate revenues from the commercialization of any
of these products. Our long-term viability will be impaired if we are unable to
obtain regulatory approval for, or successfully market, our product candidates.
To date, we have only generated revenues from investments, research grants and
collaborative research and development agreements. We will need to engage in
significant, time-consuming and costly research, development, pre-clinical
studies, clinical testing and regulatory approval for our products under
development prior to their commercialization. In addition, pre-clinical or
clinical studies may show that our products are not effective or safe for one or
more of their intended uses. We may fail in the development and
commercialization of our products. As of September 30, 2003, we have incurred a
deficit accumulated during the development stage of approximately $88.2 million,
and we expect to continue to incur significant increasing operating losses over
the next several years. If we succeed in the development of our products, we
still may not generate sufficient or sustainable revenues or we may not be
profitable.
Page 13
Our technology platform is based solely on our proprietary humanized, engineered
surfactant technology and only our lead product candidate, Surfaxin, has been
subject to clinical studies. Our ongoing clinical trials for Surfaxin for the
treatment of Respiratory Distress Syndrome in premature infants may be delayed,
or fail, which will harm our business.
Our humanized, engineered surfactant platform technology is based on the
scientific rationale for surfactant replacement therapy to treat life
threatening respiratory disorders and as the foundation for the development of
novel respiratory therapies and products. Our business is dependent upon the
successful development and approval of our product candidates based on this
platform technology. Our lead product, Surfaxin, is currently in a Phase 3
clinical trial for Respiratory Distress Syndrome in premature infants, a Phase 2
clinical trial for Acute Respiratory Distress syndrome in adults and a Phase 3
and a Phase 2 clinical trial for Meconium Aspiration Syndrome in full-term
infants.
Companies in the pharmaceutical and biotechnology industries have suffered
significant setbacks in advanced clinical trials, even after obtaining promising
results in earlier trials. Data obtained from tests are susceptible to varying
interpretations which may delay, limit or prevent regulatory approval. In
addition, we may be unable to enroll patients quickly enough to meet our
expectations for completing any or all of these trials. The timing and
completion of current and planned clinical trials of our product candidates
depend on, among other factors, the rate at which patients are enrolled, which
is a function of many factors, including:
- -- the number of clinical sites;
- -- the size of the patient population;
- -- the proximity of patients to the clinical sites;
- -- the eligibility criteria for the study;
- -- the existence of competing clinical trials; and
- -- the existence of alternative available products.
Delays in patient enrollment in clinical trials may occur, which would likely
result in increased costs, program delays or both.
We will need additional capital, and our ability to continue all of our existing
planned research and development activities is uncertain. Any additional
financing could result in equity dilution.
We will need substantial additional funding to conduct our presently planned
research and product development activities. Based on our current operating
plan, we believe that our currently available financial resources will be
adequate to satisfy our capital needs into 2005. Our future capital requirements
will depend on a number of factors that are uncertain, including the results of
our research and development activities, clinical studies and trials,
competitive and technological advances and the regulatory process, among others.
We will likely need to raise substantial additional funds through collaborative
ventures with potential corporate partners and through additional debt or equity
financings. We may also continue to seek additional funding through capital
lease transactions. We may in some cases elect to develop products on our own
instead of entering into collaboration arrangements. This would increase our
cash requirements for research and development.
We have not entered into arrangements to obtain any additional financing, except
for the credit facility with PharmaBio and our capital equipment lease financing
arrangement with General Electric Capital Corporation. Any additional financing
could include unattractive terms or result in significant dilution of
stockholders' interests and share prices may decline. If we fail to enter into
collaborative ventures or to receive additional funding, we may have to delay,
scale back or discontinue certain of our research and development operations,
and consider licensing the development and commercialization of products that we
consider valuable and which we otherwise would have developed ourselves. If we
are unable to raise required capital, we may be forced to limit many, if not
all, of our research and development programs and related operations, curtail
commercialization of our product candidates and, ultimately, cease operations.
Page 14
Furthermore, we could cease to qualify for listing of our securities on the
NASDAQ SmallCap Market if the market price of our common stock declines as a
result of the dilutive aspects of such potential financings. See "Risks Related
to Our Business - The market price of our stock may be adversely affected by
market volatility."
The clinical trial and regulatory approval process for our products is expensive
and time consuming, and the outcome is uncertain.
In order to sell our products that are under development, we must receive
regulatory approvals for each product. The FDA and comparable agencies in
foreign countries extensively and rigorously regulate the testing, manufacture,
distribution, advertising, pricing and marketing of drug products like our
products. This approval process includes preclinical studies and clinical trials
of each pharmaceutical compound to establish its safety and effectiveness and
confirmation by the FDA and comparable agencies in foreign countries that the
manufacturer maintains good laboratory and manufacturing practices during
testing and manufacturing. Although we are involved in certain late-stage
clinical trials, pharmaceutical and biotechnology companies have suffered
significant setbacks in advanced clinical trials, even after promising results
in earlier clinical trials.
The approval process is lengthy, expensive and uncertain. It is also possible
that the FDA or comparable foreign regulatory authorities could interrupt, delay
or halt any one or more of our clinical trials. If we, or any regulatory
authorities, believe that trial participants face unacceptable health risks, any
one or more of our trials could be suspended or terminated. We also may not
reach agreement with the FDA and/or comparable foreign agencies on the design of
any one or more of the clinical studies necessary for approval. Conditions
imposed by the FDA and comparable agencies in foreign countries on our clinical
trials could significantly increase the time required for completion of such
clinical trials and the costs of conducting the clinical trials. Data obtained
from clinical trials are susceptible to varying interpretations which may delay,
limit or prevent regulatory approval.
Delays and terminations of the clinical trials we conduct could result from
insufficient patient enrollment. Patient enrollment is a function of several
factors, including the size of the patient population, stringent enrollment
criteria, the proximity of the patients to the trial sites, having to compete
with other clinical trials for eligible patients, geographical and geopolitical
considerations and others. Delays in patient enrollment can result in greater
costs and longer trial timeframes. Patients may also suffer adverse medical
events or side effects that are common to this class of drug such as a decrease
in the oxygen level of the blood upon administration.
Clinical trials generally take two to five years or more to complete, and,
accordingly, our first product is not expected to be commercially available in
the United States until at least 2004, and our other product candidates will
take longer. The FDA has notified us that two of our intended indications for
Surfaxin, Meconium Aspiration Syndrome in full-term infants and Acute
Respiratory Distress Syndrome in adults, have been granted designation as
"fast-track" products under provisions of the Food and Drug Administration
Modernization Act of 1997. The FDA has also granted us Orphan Drug Designation
for three of our intended indications for Surfaxin, Meconium Aspiration Syndrome
in full-term infants, Acute Respiratory Distress Syndrome in adults and
Respiratory Distress Syndrome in infants. To support our development of Surfaxin
for the treatment of Meconium Aspiration Syndrome, the FDA has awarded us an
Orphan Products Development Grant. Fast-Track Status does not accelerate the
clinical trials nor does it mean that the regulatory requirements are less
stringent. The Fast-Track Status provisions are designed to expedite the FDA's
review of new drugs intended to treat serious or life-threatening conditions.
The FDA generally will review the New Drug Application for a drug granted
Fast-Track Status within six months instead of the typical one to three years.
Our products may not, however, continue to qualify for expedited review and our
other drug candidates may fail to qualify for fast track development or
expedited review. Even though some of our drug candidates have qualified for
expedited review, the FDA may not approve them at all or any sooner than other
drug candidates that do not qualify for expedited review.
The FDA and comparable foreign agencies could withdraw any approvals we obtain.
Further, if there is a later discovery of unknown problems or if we fail to
comply with other applicable regulatory requirements at any stage in the
regulatory process, the FDA may restrict or delay our marketing of a product or
force us to make product recalls. In addition, the FDA could impose other
sanctions such as fines, injunctions, civil penalties or criminal prosecutions.
To market our products outside the United States, we also need to comply with
foreign regulatory requirements governing human clinical trials and marketing
approval for pharmaceutical products. The FDA and foreign regulators have not
yet approved any of our products under development for marketing in the United
States or elsewhere. If the FDA and other regulators do not approve our
products, we will not be able to market our products.
Page 15
In order to conduct our clinical trials we need adequate supplies of our drug
substance and drug product and competitor's drug product, which may not be
readily available.
To succeed, clinical trials require adequate supplies of drug substance and drug
product, which may be difficult or uneconomical to procure or manufacture. We
rely on third party contract manufacturers for our drug substance and other
active ingredients for Surfaxin and to produce material that meets appropriate
standards for use in clinical trials of our products. We recently transferred
our manufacturing capabilities from our single validated clinical manufacturing
facility, owned and operated by Akorn to a new contract manufacturer, Laureate
Pharma, with the objective of producing appropriate clinical grade material of
our drug substance that meet the standards for use in our ongoing clinical
studies. Laureate Pharma may not be able to produce Surfaxin to appropriate
standards for use in clinical studies. A failure by Laureate to do so may delay
or impair our ability to obtain regulatory approval for Surfaxin. See also
"Risks Related to Our Business - If the parties we depend on for manufacturing
our pharmaceutical products do not timely supply these products, it may delay or
impair our ability to develop and market our products."
If the parties we depend on for manufacturing our pharmaceutical products do not
timely supply these products, it may delay or impair our ability to develop and
market our products.
We rely on outside manufacturers for our drug substance and other active
ingredients for Surfaxin and to produce material that meets appropriate
standards for use in clinical studies of our products. Presently, we have no
validated clinical manufacturing facility to produce appropriate clinical grade
material of our drug substance for use in our ongoing clinical studies.
Laureate Pharma or other outside manufacturers may not be able to (i) produce
our drug substance to appropriate standards for use in clinical studies, (ii)
perform under the definitive manufacturing agreement once such agreements are
executed, if at all, or (iii) remain in the contract manufacturing business for
a sufficient time to successfully produce and market our product candidates. If
we do not maintain important manufacturing relationships, we may fail to find a
replacement manufacturer or to develop our own manufacturing capabilities. If we
cannot do so, it could delay or impair our ability to obtain regulatory approval
for our products and substantially increase our costs or deplete any profit
margins. If we do find replacement manufacturers, we may not be able to enter
into agreements with them on terms and conditions favorable to us and, there
could be a substantial delay before a new facility could be qualified and
registered with the FDA and foreign regulatory authorities.
We may in the future elect to manufacture some of our products on our own.
Although we own certain specialized manufacturing equipment, are considering an
investment in additional manufacturing equipment and employ certain
manufacturing managerial personnel, we do not presently maintain a complete
manufacturing facility or manufacturing department and we do not anticipate
manufacturing on our own any of our products during the next 12 months. If we
decide to manufacture products on our own and do not successfully develop
manufacturing capabilities, it will adversely affect sales of our products.
The FDA and foreign regulatory authorities require manufacturers to register
manufacturing facilities. The FDA and corresponding foreign regulators also
inspect these facilities to confirm compliance with good manufacturing practices
(GMPs) or similar requirements that the FDA or corresponding foreign regulators
establish. Manufacturing or quality control problems could occur at the contract
manufacturers causing product production and shipment delays or a situation
where the contractor may not be able to maintain compliance with the FDA's
current GMP requirements necessary to continue manufacturing our drug substance.
If our third-party foreign or domestic suppliers or manufacturers of our
products, or, if we decide to manufacture our products on our own, we, fail to
comply with GMP requirements or other FDA and comparable foreign regulatory
requirements, it could adversely affect our clinical research activities and our
ability to market and develop our products.
Page 16
Our strategy, in many cases, is to enter into collaboration agreements with
third parties with respect to our products and we may require additional
collaboration agreements. If we fail to enter into these agreements or if we or
the third parties do not perform under such agreements, it could impair our
ability to commercialize our products.
Our strategy for the completion of the required development and clinical testing
of our products and for the manufacturing, marketing and commercialization of
our products, in many cases, depends upon entering into collaboration
arrangements with pharmaceutical companies to market, commercialize and
distribute our products. In March 2002, we expanded our relationship with Esteve
by entering into a collaboration arrangement with Esteve for Surfaxin covering
all of Europe and Latin America. Esteve will be responsible for the marketing of
Surfaxin for the treatment of Respiratory Distress Syndrome in premature
infants, Meconium Aspiration Syndrome in full-term infants and Acute Lung
Injury/Acute Respiratory Distress Syndrome in adults. Esteve will also be
responsible for the sponsorship of certain clinical trial costs related to
obtaining European Medicines Evaluation Agency approval for commercialization of
Surfaxin in Europe for the Acute Lung Injury/Acute Respiratory Distress Syndrome
indications. We will be responsible for the remainder of the regulatory
activities relating to Surfaxin, including with respect to European Medicines
Evaluation Agency filings.
In December 2001, we entered into an exclusive collaboration arrangement in the
United States with Quintiles, and its affiliate, PharmaBio, to commercialize,
sell and market Surfaxin in the United States for indications of Respiratory
Distress Syndrome and Meconium Aspiration Syndrome. As part of our collaboration
with Quintiles, Quintiles will build a sales force solely dedicated to the sale
of Surfaxin upon the approval of a New Drug Application for either of the two
indications. If Quintiles and we fail to devote appropriate resources to
commercialize, sell and market Surfaxin, sales of Surfaxin could be reduced. As
part of the collaboration, PharmaBio is obligated to provide us with certain
financial assistance in connection with the commercialization of Surfaxin,
including, but not limited to, a secured, revolving credit facility for at least
$8.5 million which may be increased to $10 million. A failure by us to repay
amounts outstanding under the credit facility would have a material adverse
effect on us. To obtain the benefits of such financing, we are obligated to meet
certain development and performance milestones. The failure by us to meet the
milestones or other terms and conditions of the financing leading to PharmaBio's
termination thereof or the failure by PharmaBio to fulfill its obligation to
partially fund the commercialization of Surfaxin, may affect our ability to
successfully market Surfaxin.
If Esteve, Quintiles, PharmaBio or we breach or terminate the agreements that
make up such collaboration arrangements or Esteve, Quintiles or PharmaBio
otherwise fail to conduct their Surfaxin-related activities in a timely manner
or if there is a dispute about their respective obligations, we may need to seek
other partners or we may have to develop our own internal sales and marketing
capability for the indications of Surfaxin which Esteve, Quintiles and/or
PharmaBio have agreed to assist in commercializing. Accordingly, we may need to
enter into additional collaboration agreements and our success, particularly
outside of the United States, may depend upon obtaining additional collaboration
partners. In addition, we may depend on our partners' expertise and dedication
of sufficient resources to develop and commercialize our proposed products. We
may, in the future, grant to collaboration partners rights to license and
commercialize pharmaceutical products developed under collaboration agreements.
Under these arrangements, our collaboration partners may control key decisions
relating to the development of the products. The rights of our collaboration
partners would limit our flexibility in considering alternatives for the
commercialization of our products. If we fail to successfully develop these
relationships or if our collaboration partners fail to successfully develop or
commercialize any of our products, it may delay or prevent us from developing or
commercializing our products in a competitive and timely manner and would have a
material adverse effect on the commercialization of Surfaxin. See "Risks Related
to Our Business - Our lack of marketing and sales experience could limit our
ability to generate revenues from future product sales."
If we cannot protect our intellectual property, other companies could use our
technology in competitive products. If we infringe the intellectual property
rights of others, other companies could prevent us from developing or marketing
our products.
We seek patent protection for our drug candidates so as to prevent others from
commercializing equivalent products in substantially less time and at
substantially lower expense. The pharmaceutical industry places considerable
importance on obtaining patent and trade secret protection for new technologies,
products and processes. Our success will depend in part on our ability and that
of parties from whom we license technology to:
Page 17
- -- defend our patents and otherwise prevent others from infringing on our
proprietary rights;
- -- protect trade secrets; and
- -- operate without infringing upon the proprietary rights of others, both in
the United States and in other countries.
The patent position of firms relying upon biotechnology is highly uncertain and
involves complex legal and factual questions for which important legal
principles are unresolved. To date, the United States Patent and Trademark
Office has not adopted a consistent policy regarding the breadth of claims that
the United States Patent and Trademark Office allows in biotechnology patents or
the degree of protection that these types of patents afford. As a result, there
are risks that we may not develop or obtain rights to products or processes that
are or may seem to be patentable.
Even if we obtain patents to protect our products, those patents may not be
sufficiently broad and others could compete with us.
We, and the parties licensing technologies to us, have filed various United
States and foreign patent applications with respect to the products and
technologies under our development, and the United States Patent and Trademark
Office and foreign patent offices have issued patents with respect to our
products and technologies. These patent applications include international
applications filed under the Patent Cooperation Treaty. Our pending patent
applications, those we may file in the future or those we may license from third
parties may not result in the United States Patent and Trademark Office or
foreign patent office issuing patents. Also, if patent rights covering our
products are not sufficiently broad, they may not provide us with sufficient
proprietary protection or competitive advantages against competitors with
similar products and technologies. Furthermore, if the United States Patent and
Trademark Office or foreign patent offices issue patents to us or our licensors,
others may challenge the patents or circumvent the patents, or the patent office
or the courts may invalidate the patents. Thus, any patents we own or license
from or to third parties may not provide any protection against competitors.
Furthermore, the life of our patents is limited. We have licensed a series of
patents from Johnson & Johnson, Inc., and Ortho Pharmaceutical Corporation which
are important, either individually or collectively, to our strategy of
commercializing our surfactant technology. Such patents, which include relevant
European patents, expire on various dates beginning in 2009 and ending in 2020
or, in some cases, possibly later. We have filed, and when possible and
appropriate, will file, other patent applications with respect to our products
and processes in the United States and in foreign countries. We may not be able
to develop additional products or processes that will be patentable or
additional patents may not be issued to us. See also "Risks Related to Our
Business - If we cannot meet requirements under our license agreements, we could
lose the rights to our products."
Intellectual property rights of third parties could limit our ability to market
our products.
Our commercial success also significantly depends on our ability to operate
without infringing the patents or violating the proprietary rights of others.
The United States Patent and Trademark Office keeps United States patent
applications confidential while the applications are pending. As a result, we
cannot determine which inventions third parties claim in pending patent
applications that they have filed. We may need to engage in litigation to defend
or enforce our patent and license rights or to determine the scope and validity
of the proprietary rights of others. It will be expensive and time consuming to
defend and enforce patent claims. Thus, even in those instances in which the
outcome is favorable to us, the proceedings can result in the diversion of
substantial resources from our other activities. An adverse determination may
subject us to significant liabilities or require us to seek licenses that third
parties may not grant to us or may only grant at rates that diminish or deplete
the profitability of the products to us. An adverse determination could also
require us to alter our products or processes or cease altogether any related
research and development activities or product sales.
If we cannot meet requirements under our license agreements, we could lose the
rights to our products.
We depend on licensing arrangements with third parties to maintain the
intellectual property rights to our products under development. Presently, we
have licensed rights from Johnson & Johnson and Ortho Pharmaceutical. These
agreements require us to make payments and satisfy performance obligations in
order to maintain our rights under these licensing arrangements. All of these
agreements last either throughout the life of the patents, or with respect to
other licensed technology, for a number of years after the first commercial sale
of the relevant product.
Page 18
In addition, we are responsible for the cost of filing and prosecuting certain
patent applications and maintaining certain issued patents licensed to us. If we
do not meet our obligations under our license agreements in a timely manner, we
could lose the rights to our proprietary technology.
In addition, we may be required to obtain licenses to patents or other
proprietary rights of third parties in connection with the development and use
of our products and technologies. Licenses required under any such patents or
proprietary rights might not be made available on terms acceptable to us, if at
all.
We rely on confidentiality agreements that could be breached and may be
difficult to enforce.
Although we believe that we take reasonable steps to protect our intellectual
property, including the use of agreements relating to the non-disclosure of
confidential information to third parties, as well as agreements that purport to
require the disclosure and assignment to us of the rights to the ideas,
developments, discoveries and inventions of our employees and consultants while
we employ them, the agreements can be difficult and costly to enforce. Although
we seek to obtain these types of agreements from our consultants, advisors and
research collaborators, to the extent that they apply or independently develop
intellectual property in connection with any of our projects, disputes may arise
as to the proprietary rights to this type of information. If a dispute arises, a
court may determine that the right belongs to a third party, and enforcement of
our rights can be costly and unpredictable. In addition, we will rely on trade
secrets and proprietary know-how that we will seek to protect in part by
confidentiality agreements with our employees, consultants, advisors or others.
Despite the protective measures we employ, we still face the risk that:
- -- they will breach these agreements;
- -- any agreements we obtain will not provide adequate remedies for this type
of breach or that our trade secrets or proprietary know-how will otherwise
become known or competitors will independently develop similar technology;
and
- -- our competitors will independently discover our proprietary information
and trade secrets.
Our lack of marketing and sales experience could limit our ability to generate
revenues from future product sales.
We do not have marketing, sales or distribution experience or marketing or sales
personnel. As a result, we will depend on our collaboration with Quintiles for
the marketing and sales of Surfaxin for indications of Respiratory Distress
Syndrome in premature infants and Meconium Aspiration Syndrome in full-term
infants in the United States and with Esteve for the marketing and sales of
Surfaxin for the treatment of Respiratory Distress Syndrome, Meconium Aspiration
Syndrome and Acute Lung Injury/Acute Respiratory Distress Syndrome in adult
patients in all of Europe and Latin America. See "Risks Related to Our Business
- - Our strategy, in many cases, is to enter into collaboration agreements with
third parties with respect to our products and we may require additional
collaboration agreements. If we fail to enter into these agreements or if we or
the third parties do not perform under such agreements, it could impair our
ability to commercialize our products." If we do not develop a marketing and
sales force of our own, then we will depend on arrangements with corporate
partners or other entities for the marketing and sale of our remaining products.
The sales and marketing of Surfaxin for indications of Respiratory Distress
Syndrome in premature infants, Meconium Aspiration Syndrome in full-term
infants, and Acute Lung Injury/Acute Respiratory Distress Syndrome in adult
patients in the relevant territories depends, in part, on Quintiles' and
Esteve's performance of their contractual obligations. The failure of either
party to do so would have a material adverse effect on the sales and marketing
of Surfaxin. We may not succeed in entering into any satisfactory third party
arrangements for the marketing and sale of our remaining products. In addition,
we may not succeed in developing marketing and sales capabilities, our
commercial launch of certain products may be delayed until we establish
marketing and sales capabilities or we may not have sufficient resources to do
so. If we fail to establish marketing and sales capabilities or fail to enter
into arrangements with third parties, either in a timely manner, it will
adversely affect sales of our products.
Page 19
We depend upon key employees and consultants in a competitive market for skilled
personnel. If we are unable to attract and retain key personnel, it could
adversely affect our ability to develop and market our products.
We are highly dependent upon the principal members of our management team,
especially our Chief Executive Officer, Dr. Capetola, and our directors, as well
as our scientific advisory board members, consultants and collaborating
scientists. Many of these people have been involved in our formation or have
otherwise been involved with us for many years, have played integral roles in
our progress and we believe that they will continue to provide value to us. A
loss of any of these personnel may have a material adverse effect on aspects of
our business and clinical development and regulatory programs. We have an
employment agreement with Dr. Capetola that expires on December 31, 2005. We
also have employment agreements with other key personnel with termination dates
from 2003 through 2005. Although these employment agreements generally provide
for severance payments that are contingent upon the applicable employee's
refraining from competition with us, the loss of any of these persons' services
would adversely affect our ability to develop and market our products and obtain
necessary regulatory approvals, and the applicable noncompete provisions can be
difficult and costly to monitor and enforce. Further, we do not maintain key-man
life insurance.
Our future success also will depend in part on the continued service of our key
scientific and management personnel and our ability to identify, hire and retain
additional personnel, including marketing and sales staff. We experience intense
competition for qualified personnel, and the existence of non-competition
agreements between prospective employees and their former employers may prevent
us from hiring those individuals or subject us to suit from their former
employers.
While we attempt to provide competitive compensation packages to attract and
retain key personnel, some of our competitors are likely to have greater
resources and more experience than we have, making it difficult for us to
compete successfully for key personnel.
Our industry is highly competitive and we have less capital and resources than
many of our competitors, which may give them an advantage in developing and
marketing products similar to ours or make our products obsolete.
Our industry is highly competitive and subject to rapid technological innovation
and evolving industry standards. We compete with numerous existing companies
intensely in many ways. We intend to market our products under development for
the treatment of diseases for which other technologies and treatments are
rapidly developing and, consequently, we expect new companies to enter our
industry and that competition in the industry will increase. Many of these
companies have substantially greater research and development, manufacturing,
marketing, financial, technological, personnel and managerial resources than we
have. In addition, many of these competitors, either alone or with their
collaborative partners, have significantly greater experience than we do in:
- -- developing products;
- -- undertaking preclinical testing and human clinical trials;
- -- obtaining FDA and other regulatory approvals or products; and
- -- manufacturing and marketing products.
Accordingly, our competitors may succeed in obtaining patent protection,
receiving FDA or comparable foreign approval or commercializing products before
us. If we commence commercial product sales, we will compete against companies
with greater marketing and manufacturing capabilities who may successfully
develop and commercialize products that are more effective or less expensive
than ours. These are areas in which, as yet, we have limited or no experience.
In addition, developments by our competitors may render our product candidates
obsolete or noncompetitive.
Presently, there are no approved drugs that are specifically indicated for
Meconium Aspiration Syndrome in full-term infants or Acute Lung Injury/Acute
Respiratory Distress Syndrome in adults. Current therapy consists of general
supportive care and mechanical ventilation.
Four products, three that are animal-derived and one that is a synthetic, are
specifically approved for the treatment of Respiratory Distress Syndrome in
premature infants. Exosurf(R) is synthetic and is marketed by GlaxoSmithKline,
plc, outside the United States and contains only phospholipids (the fats
normally present in the lungs) and synthetic organic detergents and no
stabilizing protein or peptides. Curosurf(R) is a porcine lung extract that is
Page 20
marketed in Europe by Chiesi Farmaceutici S.p.A., and in the United States by
Dey Laboratories, Inc. Survanta(R), marketed by the Ross division of Abbott
Laboratories, Inc., is an extract of bovine lung that contains the cow version
of surfactant protein C. Forest Laboratories, Inc., markets its calf lung
surfactant, Infasurf(R) in the United States for the treatment of Respiratory
Distress Syndrome in premature infants. Although none of the four approved
surfactants for Respiratory Distress Syndrome in premature infants is approved
for Acute Lung Injury or Acute Respiratory Distress Syndrome in adults, which
are significantly larger markets, there are a significant number of other
potential therapies in development for the treatment of Acute Lung Injury/Acute
Respiratory Distress Syndrome that are not surfactant-related. Any of these
various drugs or devices could significantly impact the commercial opportunity
for Surfaxin. We believe that engineered humanized surfactants such as Surfaxin
will be far less expensive to produce than the animal-derived products approved
for the treatment of Respiratory Distress Syndrome in premature infants and will
have no capability of transmitting the brain-wasting bovine spongiform
encephalopathy (commonly called "mad-cow disease") or causing adverse
immunological responses in young and older adults.
We also face, and will continue to face, competition from colleges,
universities, governmental agencies and other public and private research
organizations. These competitors are becoming more active in seeking patent
protection and licensing arrangements to collect royalties for use of technology
that they have developed. Some of these technologies may compete directly with
the technologies that we are developing. These institutions will also compete
with us in recruiting highly qualified scientific personnel. We expect that
therapeutic developments in the areas in which we are active may occur at a
rapid rate and that competition will intensify as advances in this field are
made. As a result, we need to continue to devote substantial resources and
efforts to research and development activities.
If product liability claims are brought against us, it may result in reduced
demand for our products or damages that exceed our insurance coverage.
The clinical testing of, marketing and use of our products exposes us to product
liability claims in the event that the use or misuse of those products causes
injury, disease or results in adverse effects. Use of our products in clinical
trials, as well as commercial sale, could result in product liability claims. In
addition, sales of our products through third party arrangements could also
subject us to product liability claims. We presently carry product liability
insurance with coverages of up to $10,000,000 per occurrence and $10,000,000 in
the aggregate, an amount we consider reasonable and customary relating to our
clinical trials of Surfaxin. However, this insurance coverage includes various
deductibles, limitations and exclusions from coverage, and in any event might
not fully cover any potential claims. We may need to obtain additional product
liability insurance coverage prior to initiating other clinical trials. We
expect to obtain product liability insurance coverage before commercialization
of our proposed products; however, the insurance is expensive and insurance
companies may not issue this type of insurance when we need it. We may not be
able to obtain adequate insurance in the future at an acceptable cost. Any
product liability claim, even one that was not in excess of our insurance
coverage or one that is meritless and/or unsuccessful, could adversely affect
our cash available for other purposes, such as research and development. In
addition, the existence of a product liability claim could affect the market
price of our common stock.
We expect to face uncertainty over reimbursement and healthcare reform.
In both the United States and other countries, sales of our products will depend
in part upon the availability of reimbursement from third party payors, which
include government health administration authorities, managed care providers and
private health insurers. Third party payors are increasingly challenging the
price and examining the cost effectiveness of medical products and services.
Directors, executive officers, principal stockholders and affiliated entities
own a significant percentage of our capital stock, and they may make decisions
that you do not consider to be in your best interest.
As of September 30, 2003, our directors, executive officers, principal
stockholders and affiliated entities beneficially owned, in the aggregate,
approximately 15% of our outstanding voting securities. As a result, if some or
all of them acted together, they would have the ability to exert substantial
influence over the election of our Board of Directors and the outcome of issues
requiring approval by our stockholders. This concentration of ownership may have
the effect of delaying or preventing a change in control of our Company that may
be favored by other stockholders. This could prevent transactions in which
stockholders might otherwise recover a premium for their shares over current
market prices.
Page 21
The market price of our stock may be adversely affected by market volatility.
The market price of our common stock, like that of many other development stage
pharmaceutical or biotechnology companies, has been and is likely to be
volatile. In addition to general economic, political and market conditions, the
price and trading volume of our stock could fluctuate widely in response to many
factors, including:
- -- announcements of the results of clinical trials by us or our competitors;
- -- adverse reactions to products;
- -- governmental approvals, delays in expected governmental approvals or
withdrawals of any prior governmental approvals or public or regulatory
agency concerns regarding the safety or effectiveness of our products;
- -- changes in the United States or foreign regulatory policy during the
period of product development;
- -- developments in patent or other proprietary rights, including any third
party challenges of our intellectual property rights;
- -- announcements of technological innovations by us or our competitors;
- -- announcements of new products or new contracts by us or our competitors;
- -- actual or anticipated variations in our operating results due to the level
of development expenses and other factors;
- -- changes in financial estimates by securities analysts and whether our
earnings meet or exceed the estimates;
- -- conditions and trends in the pharmaceutical and other industries;
- -- new accounting standards; and
- -- the occurrence of any of the risks described in this "Management's
Discussion and Analysis - Risks Related to Our Business."
Our common stock is listed for quotation on the NASDAQ SmallCap Market. For the
nine-month period ended September 30, 2003, the price of our common stock has
ranged from $1.32 to $8.50. We expect the price of our common stock to remain
volatile. The average daily trading volume in our common stock varies
significantly. For the nine-month period ending September 30, 2003, the average
daily trading volume in our common stock was approximately 308,000 shares and
the average number of transactions per day was approximately 500. Our relatively
low average volume and low average number of transactions per day may affect the
ability of our stockholders to sell their shares in the public market at
prevailing prices and a more active market may never develop.
In addition, we may not be able to continue to adhere to the strict listing
criteria of the SmallCap Market. If the common stock were no longer listed on
the SmallCap Market, investors might only be able to trade in the
over-the-counter market in the Pink Sheets(R) (a quotation medium operated by
the National Quotation Bureau, LLC) or on the OTC Bulletin Board(R) of the
National Association of Securities Dealers, Inc. This would impair the liquidity
of our securities not only in the number of shares that could be bought and sold
at a given price, which might be depressed by the relative illiquidity, but also
through delays in the timing of transactions and reduction in media coverage.
In the past, following periods of volatility in the market price of the
securities of companies in our industry, securities class action litigation has
often been instituted against companies in our industry. If we face securities
litigation in the future, even if meritless or unsuccessful, it would result in
substantial costs and a diversion of management attention and resources, which
would negatively impact our business.
A substantial number of our securities are eligible for future sale and this
could affect the market price for our stock and our ability to raise capital.
The market price of our common stock could drop due to sales of a large number
of shares of our common stock or the perception that these sales could occur. As
of September 30, 2003, we had 42,080,094 shares of common stock issued and
outstanding. In addition, as of September 30, 2003, up to approximately
9,026,000 shares of our common stock were issuable upon exercise of outstanding
options and warrants.
Holders of our stock options and warrants are likely to exercise them, if ever,
at a time when we otherwise could obtain a price for the sale of our securities
that is higher than the exercise price per security of the options or warrants.
This exercise, or the possibility of this exercise, may impede our efforts to
obtain additional financing through the sale of additional securities or make
this financing more costly, and may reduce the price of our common stock.
Page 22
Provisions of our Certificate of Incorporation and Delaware law could defer a
change of our management which could discourage or delay offers to acquire us.
Provisions of our Certificate of Incorporation and Delaware law may make it more
difficult for someone to acquire control of us or for our stockholders to remove
existing management, and might discourage a third party from offering to acquire
us, even if a change in control or in management would be beneficial to our
stockholders. For example, our Certificate of Incorporation allows us to issue
shares of preferred stock without any vote or further action by our
stockholders. Our Board of Directors has the authority to fix and determine the
relative rights and preferences of preferred stock. Our Board of Directors also
has the authority to issue preferred stock without further stockholder approval,
including large blocks of preferred stock. As a result, our Board of Directors
could authorize the issuance of a series of preferred stock that would grant to
holders the preferred right to our assets upon liquidation, the right to receive
dividend payments before dividends are distributed to the holders of common
stock and the right to the redemption of the shares, together with a premium,
prior to the redemption of our common stock.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk is confined to our cash, cash equivalents and
available for sale securities. We place our investments with high quality
issuers and, by policy, limit the amount of credit exposure to any one issuer.
We currently do not hedge interest rate or currency exchange exposure. We
classify highly liquid investments purchased with a maturity of three months or
less as "cash equivalents" and commercial paper and fixed income mutual funds as
"available for sale securities." Fixed income securities may have their fair
market value adversely affected due to a rise in interest rates and we may
suffer losses in principal if forced to sell securities that have declined in
market value due to a change in interest rates.
Item 4. CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures. In designing and
evaluating the disclosure controls and procedures, our management
recognized that any controls and procedures, no matter how well designed
and operated, can provide only reasonable assurance of achieving the
desired control objectives and our management necessarily was required to
apply its judgment in evaluating the cost-benefit relationship of possible
controls and procedures. Our principal executive and financial officers
reviewed and evaluated our disclosure controls and procedures (as defined
in Rule 13a-14 promulgated under the Securities Exchange Act of 1934)
prior to the filing of this Quarterly Report. Based on that evaluation,
our principal executive and financial officers concluded that our
disclosure controls and procedures are effective in timely providing them
with material information, as required to be disclosed in the reports we
file pursuant to the Exchange Act.
(b) Changes in internal controls. There were no significant changes in our
internal controls or other factors that could significantly affect those
controls subsequent to the date of our evaluation, including any
corrective actions with regard to significant deficiencies and material
weaknesses.
Page 23
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
None.
ITEM 2. CHANGE IN SECURITIES AND USE OF PROCEEDS.
In the quarter ended September 30, 2003, we granted an aggregate of 788,000
options to our employees and consultants at various exercise prices ranging from
$6.75 per share to $8.08 per share. We claimed the exemption from registration
provided by Section 4(2) of the Securities Act for these transactions. No
broker/dealers were involved in the sale and no commissions were paid.
In the quarter ended September 30, 2003, pursuant to the exercise of outstanding
warrants and options, we issued an aggregate of 3,716,979 shares of our common
stock at various exercise prices ranging from $0.0026 per share to $4.22 per
share. We claimed the exemption from registration provided by Section 4(2) of
the Securities Act for these transactions. No broker/dealers were involved in
the sale and no commissions were paid by us.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
At an annual meeting of the stockholders of the Company, held on July 15, 2003,
the following matters were voted on by the stockholders: (i) the election of
five directors; (ii) the approval of Ernst and Young LLP as the Company's
independent auditors for the fiscal year ended December 31, 2003; and (iii)
consideration and approval of an amendment to the 1998 Amended and Restated
Stock Incentive Plan (the "Plan") to increase the number of shares of Common
Stock available for issuance under the Plan by 1,420,000 shares.
(i) Election of Directors
For Withheld
--- --------
Robert J. Capetola, Ph.D. 19,480,644 1,803,739
Antonio Esteve, Ph.D. 20,395,746 888,637
Max Link, Ph.D. 20,357,423 926,960
Herbert H. McDade, Jr. 20,395,246 889,137
Marvin E. Rosenthale, Ph.D. 20,357,783 926,600
(ii) Approval of Independent Auditors
For Against Abstain
--- ------- -------
21,234,647 40,486 9,250
(iii) Amendment to the 1998 Amended and Restated Stock Incentive Plan
For Against Abstain
--- ------- -------
19,129,183 2,106,078 49,122
ITEM 5. OTHER INFORMATION.
None
Page 24
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
(a) Exhibits:
31.1 Section 302 Certification of Chief Executive Officer
31.2 Section 302 Certification of Chief Financial Officer
32 Section 906 Certification of Chief Executive Officer and Chief
Financial Officer
(b) Reports on Form 8-K:
One current report on Form 8-K was filed on August 12, 2003, announcing
financial results for the second quarter of 2003 and providing selected
updates on our progress since the end of the first quarter including the
transferring of the Surfaxin(R) manufacturing capabilities to a new
contract facility.
Signatures, and Certifications of the Chief Executive Officer and the Chief
Financial Officer of the Company.
Exhibits 31.1, 31.2 and 32 to this Quarterly Report on Form 10-Q include
Certifications of our Chief Executive Officer and our Chief Financial Officer.
The first two forms of Certification are required by Rule 13a-14 under the
Exchange Act in accordance with Section 302 of the Sarbanes-Oxley Act of 2002
(the "Section 302 Certifications"). The Section 302 Certifications include
references to an evaluation of the effectiveness of the design and operation of
our "disclosure controls and procedures" and our "internal controls and
procedures for financial reporting". Item 4 of Part I of this Quarterly Report
presents the conclusions of our Chief Executive Officer and our Chief Financial
Officer about the effectiveness of such controls based on and as of the date of
such evaluation (relating to Item 4 of the Section 302 Certifications), and
contain additional information concerning disclosures to our Audit Committee and
independent auditors with regard to deficiencies in internal controls and fraud
and related matters.
The second form of Certification is being furnished solely pursuant to section
906 of the Sarbanes-Oxley Act of 2002 (subsection (a) and (b) of section 1350,
chapter 63 of title 18, United States Code) and is not being filed as part of
this Form 10-Q or as a separate disclosure document. A signed original of such
written statement required by Section 906, or other document authenticating,
acknowledging or otherwise adopting the signature that appears in typed form
within the electronic version of this written statement required by Section 906,
has been provided to us and will be retained by us and furnished to the
Securities and Exchange Commission or its staff upon request.
Page 25
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Discovery Laboratories, Inc.
(Registrant)
Date: November 14, 2003 /s/ Robert J. Capetola
----------------------------------------------
Robert J. Capetola, Ph.D.
President and Chief Executive Officer
Date: November 14, 2003 /s/ John G. Cooper
----------------------------------------------
John G. Cooper
Sr. Vice President and Chief Financial Officer
(Principal Financial Officer)
Page 26
Exhibit 31.1
CERTIFICATIONS
I, Robert J. Capetola, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Discovery Laboratories,
Inc.;
2. Based on my knowledge, this Quarterly Report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this Quarterly
Report;
3. Based on my knowledge, the financial statements, and other financial
information included in this Quarterly Report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this Quarterly Report;
4. The registrant's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e) for the registrant and we have:
a) designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the
registrant, including its consolidated subsidiaries, is made known
to us by others within those entities, particularly during the
period in which this Quarterly Report is being prepared;
b) evaluated the effectiveness of the registrant's disclosure controls
and procedures and presented in this Quarterly Report our
conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this Quarterly
Report based on such evaluation; and
c) disclosed in this Quarterly Report any change in the registrant's
internal control over financial reporting that occurred during the
registrant's most recent fiscal quarter (the registrant's fourth
fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the
registrant's internal control over financial reporting; and
5. The registrant's other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to the
registrant's auditors and the audit committee of the registrant's board of
directors (or persons performing the equivalent function):
a) all significant deficiencies and material weaknesses in the design
or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant's ability to
record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or
other employees who have a significant role in the registrant's
internal control over financial reporting.
Date: November 14, 2003 By: /s/ Robert J. Capetola
-------------------------------------
Robert J. Capetola, Ph.D.
President and Chief Executive Officer
Exhibit 31.2
CERTIFICATIONS
I, John G. Cooper, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Discovery Laboratories,
Inc.;
2. Based on my knowledge, this Quarterly Report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this Quarterly
Report;
3. Based on my knowledge, the financial statements, and other financial
information included in this Quarterly Report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this Quarterly Report;
4. The registrant's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e) for the registrant and we have:
a) designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the
registrant, including its consolidated subsidiaries, is made known
to us by others within those entities, particularly during the
period in which this Quarterly Report is being prepared;
b) evaluated the effectiveness of the registrant's disclosure controls
and procedures and presented in this Quarterly Report our
conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this Quarterly
Report based on such evaluation; and
c) disclosed in this Quarterly Report any change in the registrant's
internal control over financial reporting that occurred during the
registrant's most recent fiscal quarter (the registrant's fourth
fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the
registrant's internal control over financial reporting; and
5. The registrant's other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to the
registrant's auditors and the audit committee of the registrant's board of
directors (or persons performing the equivalent function):
a) all significant deficiencies and material weaknesses in the design
or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant's ability to
record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or
other employees who have a significant role in the registrant's
internal control over financial reporting.
Date: November 14, 2003 By: /s/ John G. Cooper
-------------------------------
John G. Cooper
Senior Vice President and
Chief Financial Officer
Exhibit 32
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO SECTION 906 OF THE
SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report on Form 10-Q of Discovery
Laboratories, Inc. (the "Company"), for the period ended September 30, 2003, as
filed with the Securities and Exchange Commission (the "Commission") on the date
hereof (the "Report"), each of the undersigned, in his capacity as an officer of
the Company, certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, that:
1. the Report fully complies with the requirements of Section 13(a) or
15(d) of the Securities Exchange Act of 1934, as amended; and
2. the information contained in the Report fairly presents, in all
material respects, the financial condition and results of operations
of the Company.
A signed original of this written statement required by Section 906
of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be
retained by the Company and furnished to the Commission or its staff upon
request.
/s/ Robert J. Capetola
-------------------------------------------------
Robert J. Capetola, Ph.D.
President and Chief Executive Officer
Date: November 14, 2003
/s/ John G. Cooper
-------------------------------------------------
John G. Cooper
Senior Vice President and Chief Financial Officer
Date: November 14, 2003